This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.

Relative change in the 6-minutes walking distance (%), as compared to baseline (BL): clinical improvement is defined as an increase of at least 10% vs BL; clinically significant deterioration is defined as a decrease of at least 30% vs BL. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]

Changes in the NYHA class (to determine the patients' clinical conditions) vs. baseline will be classified into: improved, unchanged and deteriorated. Improvement is a negative difference; deterioration is a NYHA class increase from baseline. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]

Mortality, defined as all-cause mortality, will be assessed for all patients included in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: No ]

The safety and tolerability of Ventavis will be assessed by an examination of the adverse event data collected in this study. [ Time Frame: all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]

Other safety variable [ Time Frame: At all scheduled visits (Study period is min. 2 years and max. 4 years) ] [ Designated as safety issue: Yes ]

No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)

Exclusion Criteria:

Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250640

France: National Consultative Ethics Committee for Health and Life SciencesGermany: Federal Institute for Drugs and Medical DevicesPortugal: National Pharmacy and Medicines InstituteSpain: Spanish Agency of MedicinesItaly: Ethics Committee